D-0001-2026Class II

Zydus Pharmaceuticals (USA) Inc

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-10-08

Distribution

Distributed Nationwide in the USA

Firm state

Product quantity

912 30-count bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Product description

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

Code / lot info

Lot#: E409308, Exp 12/31/2026

Other recalls SPEQ maps to Validation & Qualification

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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.